There are 3 authorized presentations of Pfizer-BioNTech COVID-19 Vaccine.  Each has specific age authorizations and storage, handling, and preparation requirements.

(1) Formulation for individuals 12 years and older (DILUTE BEFORE USE/purple cap);

(2) Formulation for individuals 12 years and older (DO NOT DILUTE/gray cap); and

(3) Formulation for individuals 5 through 11 years (DILUTE BEFORE USE/orange cap).

The U.S. Food and Drug Administration (FDA)-approved COMIRNATY (COVID-19 Vaccine, mRNA) and the Emergency Use Authorization (EUA) authorized formulations of Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older, when prepared according to their respective instructions for use, can be used interchangeably without presenting any safety or effectiveness concerns, but should not be used for individuals 5 through 11 years of age, because of the potential for vaccine administration errors, including dosing errors.

COMIRNATY (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine that is indicated for active immunization to prevent COVID-19 in individuals 16 years of age and older. It is approved for use as a 2-dose primary series for the prevention of COVID-19 in individuals 16 years of age and older. It is also authorized for emergency use to provide a 2-dose primary series to individuals 12 through 15 years.

Pfizer-BioNTech COVID-19 Vaccine (purple or gray cap) is authorized for use to provide a 2-dose primary series to individuals 12 years of age and older.

COMIRNATY and the Pfizer-BioNTech COVID-19 Vaccine (purple or gray cap) are authorized for use under an EUA from FDA to provide a third primary series dose in individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise and as a first booster dose to individuals 12 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY.  The vaccines are also authorized as a first booster dose to individuals 18 years of age and older who have completed primary vaccination with another authorized or approved COVID-19 vaccine.  The vaccines are also authorized as a second booster dose to individuals 50 years of age and older who have received a first booster dose of any authorized or approved COVID-19 vaccine and as a second booster dose to individuals 12 years of age and older with certain kinds of immunocompromise and who have received a first booster dose of any authorized or approved COVID-19 vaccine.

Pfizer-BioNTech COVID-19 Vaccine (orange cap) is authorized for use to provide: a 2-dose primary series to individuals 5 through 11 years of age; a third primary series dose to individuals 5 through 11 years of age with certain kinds of immunocompromise; and a single booster dose to individuals 5 through 11 years of age who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine.

The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.